2. INTRODUCTION
• Brand Name : Olysio
• Approved Date : Nov. 22, 2013
• Company Name : Janssen Therapeutics
• Drug Category : Shedule-H
• Pharmacologic Drug Category : NS3/4A Protease Inhibitor
• Pregnancy Category : X
Olysio™ is The First Once-daily Protease Inhibitor Approved For The Treatment
Of Chronic Hepatitis C In A Combination Antiviral Regimen For Adults With
Compensated Liver Disease.
3. INDICATION :
• OLYSIO is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the
treatment of chronic hepatitis C (CHC) infection as a component of a combination
antiviral treatment regimen.
• OLYSIO efficacy has been established in combination with peginterferon-alfa and
ribavirin (P/R), in HCV genotype 1 (G1) infected subjects with compensated liver disease
(including cirrhosis).
• The following points should be considered when initiating OLYSIO for treatment of CHC
infection:
• OLYSIO must not be used as monotherapy.
• OLYSIO efficacy in combination with P/R is influenced by baseline host and viral factors.
• OLYSIO efficacy has not been studied in patients who have previously failed therapy with
a treatment regimen that includes OLYSIO or other HCV protease inhibitors.
4. DOSAGE AND ADMINISTRATION :
• One 150 Mg Capsule Taken Once Daily With Food.
• Olysio Should Be Administered With Both Peginterferon Alfa And Ribavirin.
The Recommended Treatment Duration Of OLYSIO With Peginterferon Alfa
And Ribavirin Is 12 Weeks, Followed By Either 12 Or 36 Additional Weeks Of
Peginterferon Alfa And Ribavirin Depending On Prior Response Status.
• A Dose Recommendation Cannot Be Made For Patients Of East Asian
Ancestry.
• A Dose Recommendation Cannot Be Made For Patients With Moderate To
Severe Hepatic Impairment.
5. DOSAGE FORMS & STRENGTHS :
• Capsule: 150 mg
CONTRAINDICATIONS :
• All contraindications to peginterferon alfa and ribavirin also apply to OLYSIO
combination treatment with peginterferon alfa and ribavirin.
• Because ribavirin may cause birth defects and fetal death, OLYSIO in
combination with peginterferon alfa and ribavirin is contraindicated in
pregnant women and in men whose female partners are pregnant.
6. WARNINGS AND PRECAUTIONS :
Embryofetal Toxicity (Use with Ribavirin and Peginterferon Alfa): Ribavirin may
cause birth defects and fetal death and animal studies have shown interferons have
abortifacient effects; avoid pregnancy in female patients and female partners of
male patients. Patients must have a negative pregnancy test prior to initiating
therapy, use at least two effective methods of contraception during treatment, and
undergo monthly pregnancy tests.
Photosensitivity: Serious photosensitivity reactions have been observed during
combination therapy with OLYSIO, peginterferon alfa and ribavirin. Use sun
protection measures and limit sun exposure. Consider discontinuation if a
photosensitivity reaction occurs.
Rash: Rash has been observed during combination therapy with
OLYSIO, peginterferon alfa and ribavirin. Discontinue OLYSIO if severe rash
occurs.
7. ADVERSE REACTIONS :
• The most common reported adverse reactions (greater than 20% of subjects) in
subjects receiving the combination of OLYSIO with peginterferon and
ribavirin during the first 12 weeks of treatment were: rash (including
photosensitivity), pruritus and nausea.
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
8. DRUG INTERACTIONS :
• Co-administration of OLYSIO with drugs that are moderate or strong inducers
or inhibitors of CYP3A may significantly affect the plasma concentrations of
simeprevir. The potential for drug-drug interactions must be considered prior
to and during treatment.
